News Releases

- Retrospective Health Economic Data Published in Advances in Therapy Show Acthar May Be an Important Treatment Option for Patients with Multiple Sclerosis Relapses -

CHESTERFIELD, United Kingdom, July 5, 2016 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty biopharmaceutical company, today announced new retrospective health economic data on H.P. Acthar® Gel (repository corticotropin injection; RCI), which may be an option for the management of multiple sclerosis (MS) relapses. The manuscript, recently published in Advances in Therapy compares the health care resource use and costs of patients treated with Acthar to those treated with plasmapheresis (PMP) or intravenous immunoglobulin (IVIG). Researchers at the University of Washington conducted the analysis, which was supported by a grant from Mallinckrodt Pharmaceuticals.

"This study adds to the body of data discussing Acthar," said Steve Romano, MD, Senior Vice President and Chief Scientific Officer of Mallinckrodt. "We are committed to further clinical investment in MS relapse research, a critically important aspect of managing this disease."

"Managing relapses is a central concern for the overall management of MS, yet there are few studies that compare these three treatment options for multiple relapses," said Principal Investigator Ryan Hansen, Pharm.D., Ph.D., Research Assistant Professor of Pharmacy and Health Services (adjunct) at the University of Washington. "Data such as this from real-life settings can help guide decision making among health care professionals."

The cohort analysis titled, "Health Care Costs and Resource Utilization in Multiple Sclerosis Relapse Patients," aimed to describe and generate hypotheses related to health care utilization, outcomes and costs among patients with MS who experienced multiple relapses. Researchers reviewed 12- and 24-month health care utilization and costs among patients who received Acthar (n=213 and n=96, respectively) compared to patients who were treated with PMP/IVIG (n=226 and n=132, respectively), in a commercially insured U.S. population. Claims data from the Truven Health Analytics MarketScan® Commercial Claims and Encounters Databases were examined between July 1, 2007, to Dec. 31, 2012, for the 12-month analyses or through Dec. 31, 2011, for the 24-month analyses. Patients in both the 12- and 24-month analyses were followed for outcomes until Dec. 31, 2013.

Findings from this retrospective, observational study among MS patients include:

The costs of medications were increased in the group that received Acthar prescriptions, these costs were offset by 93% (among the cohort with 12 months of follow-up) and 132% (among the cohort with 24 months of follow-up) by the relative decrease in inpatient and outpatient costs among the group that received Acthar prescriptions.

Limitations of the Study

Exposure to Acthar was defined as using outpatient prescription claims data, so some patients may be subject to misclassification as they did not actually inject the medication.

This was an observational retrospective study and not a randomized controlled trial, so unmeasured factors may still confound the associations reported.

Since the study included only patients who experienced multiple relapses and who received treatments besides intravenous methylprednisolone (IVMP) for their subsequent relapses, the sample size was relatively small and results are not generalizable to the broader MS population that responds to IVMP.

Information on procedures or health care resource utilizations for which patients paid out-of-pocket are not included in the data

As with any claims-based study, data may include coding errors with diagnoses or procedures.

MS is neurologic disorder that affects the central nervous system (i.e., the brain and spinal cord).[1] Symptoms can include fatigue, balance/coordination issues, numbness or tingling, vision problems, muscle spasms, tremors and emotional changes.4 More than eight in 10 people with MS will experience a relapse, or flare-up, that brings new or worsening symptoms.[2]

About MS Relapse

MS is an autoimmune disorder with large annual costs.[3] On average, annual direct health care costs for MS patients have been shown to be about $24,000 higher compared to the non-MS population.[4] Relapses are one of the major drivers of increased costs,1 along with disease-modifying therapies (DMTs) designed to reduce inflammation and the risk of subsequent relapses.[5],[6]

The U.S. Food and Drug Administration (FDA) approved Acthar for the treatment of MS relapse in 1978. The safety and efficacy of Acthar for MS relapse was established in a randomized, double-blind, placebo-controlled multi-centered trial with 197 patients.[7]

About H.P. Acthar Gel (repository corticotropin injection) H.P. Acthar Gel (repository corticotropin injection), is an injectable drug approved by the FDA for the treatment of 19 indications. Of these 19 indications, the product currently generates substantially all of its net sales from the following on-label indications:

As an orphan monotherapy medication for the treatment of infantile spasms ("IS") in infants and children under 2 years of age.

Inducing a diuresis or a remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.

Treatment of acute exacerbations of MS in adults.

Use during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus.

Use during an exacerbation or as maintenance therapy in selected cases of systemic dermatomyositis (polymyositis).

Use as adjunct therapy for short-term administration in select cases of rheumatoid arthritis.

The company is also exploring the possibility of developing other approved indications and the possibility of pursuing FDA approval of additional indications currently unapproved in the Acthar label where there is high unmet medical need. For more information about Acthar, please visit www.acthar.com. Full prescribing information may be accessed here.

Important Safety Information

Acthar should never be administered intravenously.

Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of Acthar.

Acthar is contraindicated where congenital infections are suspected in infants.

The adverse effects of Acthar are related primarily to its steroidogenic effects.

Acthar may increase susceptibility to new infection or reactivation of latent infections.

Suppression of the hypothalamic–pituitary–adrenal (HPA) axis may occur following prolonged therapy with the potential for adrenal insufficiency after withdrawal of the medication. Cushing's Syndrome may occur during therapy but generally resolves after therapy is stopped. Monitor patients for signs and symptoms.

Monitor patients for elevation of blood pressure, salt and water retention, and hypokalemia.

Acthar often acts by masking symptoms of other diseases/disorders. Monitor patients carefully during and following discontinuation.

Acthar can cause gastrointestinal (GI) bleeding and gastric ulcer with an increased risk for perforation with certain GI disorders. Monitor for signs of bleeding.

Acthar may be associated with central nervous system effects ranging from euphoria, insomnia, irritability, mood swings, personality changes, depression, and psychosis. Existing conditions may be aggravated.

Patients with comorbid disease may have that disease worsened. Caution should be used in patients with diabetes and myasthenia gravis.

Prolonged use of Acthar may produce cataracts, glaucoma and secondary ocular infections.

Acthar is immunogenic and prolonged use may increase the risk of hypersensitivity reactions.

There is an enhanced effect in patients with hypothyroidism and those with cirrhosis of liver.

Long-term use may have negative effects on growth and physical development in children. Monitor pediatric patients.

Decrease in bone density may occur. Monitor during long-term therapy.

Pregnancy Class C: Acthar has been shown to have an embryocidal effect and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Specific adverse reactions reported in IS clinical trials in infants and children under 2 years of age included: infection, hypertension, irritability, Cushingoid symptoms, constipation, diarrhea, vomiting, pyrexia, weight gain, increased appetite, decreased appetite, nasal congestion, acne, rash, and cardiac hypertrophy. Convulsions were also reported, but these may actually be occurring because some IS patients progress to other forms of seizures and IS sometimes mask other seizures, which become visible once the clinical spasms from IS resolve.

Please see full Prescribing Information here for additional important safety information.

ABOUT MALLINCKRODT

Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical and biopharmaceutical products and therapies, as well as nuclear imaging products. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; analgesics and hemostasis products; and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing; and the Nuclear Imaging segment includes nuclear imaging agents. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

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